510(k) K870584

O.P.T.(TM) OVULATION PREDICTION TEST by Warner-Lambert Co. — Product Code CEP

K870584 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "O.P.T.(TM) OVULATION PREDICTION TEST". The FDA issued a decision of Substantially Equivalent on November 25, 1987. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.